Omakyn
Vynix LLC
Affordable, fixed-price FDA cybersecurity gap analysis for medical device makers. Get an instant, free readiness snapshot and transparent pricing for submission-ready documentation.
About
**Who they are**<br>Omakyn is a focused FDA Section 524B premarket cybersecurity partner for small and early-stage medical device manufacturers and the regulatory/RA-QA consultants who serve them. We make cybersecurity readiness affordable and clear — starting free, with transparent fixed prices.<br><br>**What you get**<br>Start with our free online Gap Analyzer for an instant readiness snapshot. When you're ready, book a fixed-price engagement delivered by a specialist: a structured gap analysis against FDA's cybersecurity expectations, a simulated review of your device's security posture, and submission-ready documentation.<br><br>**Scope**<br>- Analyzes devices against the 9 compliance areas of FDA's premarket cybersecurity guidance.<br>- Gap analysis + simulated security lab. We do not perform penetration testing.<br>- Built for small/early-stage manufacturers and their consultants — accessible pricing, no enterprise minimums.
Additional information
Omakyn lowers the barrier to FDA 524B cybersecurity. The free online Gap Analyzer gives you a prioritized readiness snapshot in minutes — ideal for teams just beginning to scope cybersecurity or gauging readiness before committing to a submission timeline. When you need the real deliverable, you book a fixed-price engagement: a specialist-delivered gap analysis across the 9 compliance areas of FDA's premarket cybersecurity guidance, a simulated review of your device's security posture, and submission-ready documentation — with transparent, fixed pricing and no custom quotes.
Key Highlights
- Start free — instant FDA cybersecurity readiness snapshot, no sales call.
- Transparent fixed pricing — see the price before you commit.
- Specialist-delivered gap analysis across the 9 compliance areas of FDA's premarket cybersecurity guidance.
- Focused scope: gap analysis + simulated security lab (no penetration testing).
Certifications & Trust Signals
- FDA Section 524B makes premarket cybersecurity mandatory for cyber devices — a documented gap analysis is now table stakes for clearance.
- Focused exclusively on medical device cybersecurity readiness; fixed-price, remote delivery.
Buyer Snapshot
Best for
- Small and early-stage medical device makers needing affordable FDA cybersecurity readiness.
- Companies identifying compliance gaps before an FDA submission.
- Regulatory/RA-QA consultants needing a reliable cybersecurity partner for clients.
How engagement typically works
- Free self-serve readiness snapshot to start.
- Specialist-delivered, fixed-price assessment.
- Transparent pricing — no custom quotes.
Typical deliverables
- Prioritized FDA 524B cybersecurity gap report.
- Simulated security review of your device.
- Submission-ready cybersecurity documentation.
Good to know
- Best for small/early-stage manufacturers who want clear, affordable cybersecurity readiness — not enterprise pricing or penetration testing.
Pricing
Model:
Per project
Public range:
Publicly listed: $2 - $4,997
Notes:
Based on publicly listed information; final fees depend on scope.
“$8.9; $2; $1,497; $4,997; $50”
Facts
Examples & Achievements
- Free FDA 524B Gap Analyzer — instant readiness snapshot, no sales call required
- Transparent fixed pricing — see the price before you commit, no custom quotes
- Focused 524B scope: gap analysis + simulated security lab + submission-ready docs
- Fast turnaround — Starter ~1 week, Full Assessment ~2–3 weeks
- Built for small & early-stage manufacturers and their RA/QA consultants
- 100% remote, US FDA-focused
- Transparent fixed pricing — see the price before you commit, no custom quotes
- Focused 524B scope: gap analysis + simulated security lab + submission-ready docs
- Fast turnaround — Starter ~1 week, Full Assessment ~2–3 weeks
- Built for small & early-stage manufacturers and their RA/QA consultants
- 100% remote, US FDA-focused
More about our services
Our services are designed for clarity and speed:
**Services:**
* **FDA 524B Cybersecurity Gap Analyzer:** A free, instant online tool to get a snapshot of your readiness.
* **Cybersecurity Gap Analysis (Starter):** A structured 524B gap analysis with a prioritized remediation list for a fixed price of $1,497.
* **Full Cybersecurity Assessment:** A comprehensive package including the gap analysis, a simulated security lab review, and submission-ready documentation for $4,997.
**Onboarding Process:**
1. Start with the free online Gap Analyzer.
2. Book a fixed-price service directly.
3. Securely provide device and architecture documentation for kickoff.
4. Receive your detailed report.
5. Join a review call to discuss findings and next steps.
**Services:**
* **FDA 524B Cybersecurity Gap Analyzer:** A free, instant online tool to get a snapshot of your readiness.
* **Cybersecurity Gap Analysis (Starter):** A structured 524B gap analysis with a prioritized remediation list for a fixed price of $1,497.
* **Full Cybersecurity Assessment:** A comprehensive package including the gap analysis, a simulated security lab review, and submission-ready documentation for $4,997.
**Onboarding Process:**
1. Start with the free online Gap Analyzer.
2. Book a fixed-price service directly.
3. Securely provide device and architecture documentation for kickoff.
4. Receive your detailed report.
5. Join a review call to discuss findings and next steps.
HQ:
Sheridan, US
Languages:
English, Spanish
Timezones:
America/Denver
Claim status:
Claimed
Services & Capabilities
Medical Device Cybersecurity
Jurisdictions:
US
Industries:
Medical Devices
Portfolio:
1-5, 6-25
Flags:
fast_onboarding
Response SLA:
24 hours
Onboarding time:
1–3 days
Pricing model:
Per project
Starting from:
USD 1,497
Included services:
FDA 524B gap analysis, Prioritized remediation list, Simulated security review, Submission-ready documentation
Provider Type:
Both
Service Categories:
Threat Modeling & Risk Analysis
Submission Stage Support:
Pre-Submission (Planning), Ready for 510(k)/MDR Submission
Device Types Supported:
Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
Sbom Formats Supported:
CycloneDX
Standards Frameworks:
FDA Section 524B, NIST Cybersecurity Framework
Pen Testing Available:
No
Threat Modeling Available:
Yes
Sbom Management Available:
No
Vulnerability Monitoring Available:
No
Rta Rescue Available:
No
Additional medical_device_cybersecurity Details
Provider Type
Software Platform
Service Categories
Penetration Testing, SBOM Management, Threat Modeling
Submission Stage Support
Pre‑Submission, Ready for 510(k)/MDR
Device Types Supported
SaMD, connected hardware
Sbom Formats Supported
CycloneDX
Standards Frameworks
FDA Cybersecurity Guidance, FDA AI/ML Guidance
